Trial Outcomes & Findings for The Effect of Electronic Cigarette Liquid Characteristics in Smokers. (NCT NCT03861078)
NCT ID: NCT03861078
Last Updated: 2022-12-23
Results Overview
Change in plasma nicotine concentration. Changes in plasm nicotine concentration during puff bout are considered to be the more relevant and accurate values so analysis and results reporting will focus on change from baseline to immediately following 10-puff bout.
COMPLETED
NA
22 participants
Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes).
2022-12-23
Participant Flow
Each participant will participate in 5 sessions. Sessions differ by the tobacco product used (see study arms). The sessions are ordered by latin-square; however, session order was NOT expected to change any outcomes and order effects are not relevant to the study. Therefore all outcome data was merged and analyzed only by arm and session without regard to order.
Participant milestones
| Measure |
Cigarette Smokers
Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened
Own Brand Cigarette: Effects of own brand cigarette use.
ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
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|---|---|
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Overall Study
STARTED
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22
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Overall Study
Session 1: Own Brand Cigarette Use
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14
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Overall Study
Session 2: ECIG 15 mg Nicotine, Sweetened
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14
|
|
Overall Study
Session 3: ECIG Lab Session ECIG 15 mg Nicotine, Unsweetened
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14
|
|
Overall Study
Session 4: ECIG Lab Session ECIG 0 mg Nicotine, Sweetened
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14
|
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Overall Study
Session 5: ECIG Lab Session ECIG 0 mg Nicotine, Unsweetened
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14
|
|
Overall Study
COMPLETED
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14
|
|
Overall Study
NOT COMPLETED
|
8
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Reasons for withdrawal
| Measure |
Cigarette Smokers
Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened
Own Brand Cigarette: Effects of own brand cigarette use.
ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
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|---|---|
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Overall Study
COVID-19 shut down
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4
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|
Overall Study
Lost to Follow-up
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1
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Overall Study
Protocol Violation
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2
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|
Overall Study
lack of venous access
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1
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Baseline Characteristics
The Effect of Electronic Cigarette Liquid Characteristics in Smokers.
Baseline characteristics by cohort
| Measure |
Cigarette Smokers
n=14 Participants
Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened
Own Brand Cigarette: Effects of own brand cigarette use.
ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
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|---|---|
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Age, Continuous
|
37.07 years
STANDARD_DEVIATION 10.5 • n=99 Participants
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Sex: Female, Male
Female
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5 Participants
n=99 Participants
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Sex: Female, Male
Male
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9 Participants
n=99 Participants
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|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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|
Race (NIH/OMB)
Black or African American
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7 Participants
n=99 Participants
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|
Race (NIH/OMB)
White
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6 Participants
n=99 Participants
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|
Race (NIH/OMB)
More than one race
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1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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14 Participants
n=99 Participants
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Cigarettes per day
|
14.21 Cigarettes per day
STANDARD_DEVIATION 4.4 • n=99 Participants
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PRIMARY outcome
Timeframe: Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes).Population: One participant had incomplete blood data and was excluded from the analysis.
Change in plasma nicotine concentration. Changes in plasm nicotine concentration during puff bout are considered to be the more relevant and accurate values so analysis and results reporting will focus on change from baseline to immediately following 10-puff bout.
Outcome measures
| Measure |
Cigarette Smokers
n=13 Participants
Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened
Own Brand Cigarette: Effects of own brand cigarette use.
ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
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|---|---|
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Plasma Nicotine Concentration
Own Brand
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12.32 ng/ml
Standard Deviation 8.3
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Plasma Nicotine Concentration
Unsweetened, 0 mg/ml nicotine
|
-0.22 ng/ml
Standard Deviation 1.0
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Plasma Nicotine Concentration
Unsweetened, 15 mg/ml nicotine
|
7.09 ng/ml
Standard Deviation 8.6
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Plasma Nicotine Concentration
Sweetened, 15 mg/ml nicotine
|
5.85 ng/ml
Standard Deviation 7.0
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Plasma Nicotine Concentration
Sweetened, 0 mg/ml nicotine
|
-0.29 ng/ml
Standard Deviation 1.1
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PRIMARY outcome
Timeframe: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.Population: Cigarette smokers
The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Breakpoint is reported here.
Outcome measures
| Measure |
Cigarette Smokers
n=14 Participants
Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened
Own Brand Cigarette: Effects of own brand cigarette use.
ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
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|---|---|
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Progressive Ratio Task - Breakpoint
Unsweetened, 0 mg/ml nicotine
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416.07 Key presses
Standard Deviation 502.0
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Progressive Ratio Task - Breakpoint
Sweetened, 0 mg/ml nicotine
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307.29 Key presses
Standard Deviation 415.3
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Progressive Ratio Task - Breakpoint
Unsweetened, 15 mg/ml nicotine
|
336.43 Key presses
Standard Deviation 687.3
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Progressive Ratio Task - Breakpoint
Sweetened, 15 mg/ml nicotine
|
492.86 Key presses
Standard Deviation 811.0
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Progressive Ratio Task - Breakpoint
Own brand cigarette
|
812.86 Key presses
Standard Deviation 1132.3
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PRIMARY outcome
Timeframe: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.Population: Cigarette smokers
The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Number of puffs is reported here.
Outcome measures
| Measure |
Cigarette Smokers
n=14 Participants
Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened
Own Brand Cigarette: Effects of own brand cigarette use.
ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
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|---|---|
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Progressive Ratio Task - Number of Puffs
Unsweetened, 0 mg/ml nicotine
|
7.64 Number of puffs
Standard Deviation 4.2
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Progressive Ratio Task - Number of Puffs
Sweetened, 0 mg/ml nicotine
|
6.21 Number of puffs
Standard Deviation 4.7
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Progressive Ratio Task - Number of Puffs
Unsweetened, 15 mg/ml nicotine
|
5.07 Number of puffs
Standard Deviation 5.1
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Progressive Ratio Task - Number of Puffs
Sweetened, 15 mg/ml nicotine
|
7.21 Number of puffs
Standard Deviation 5.0
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Progressive Ratio Task - Number of Puffs
Own brand cigarette
|
9.93 Number of puffs
Standard Deviation 4.1
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PRIMARY outcome
Timeframe: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.Population: Cigarette smokers
The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (milliseconds) to initiate key pressing. Latency is reported here.
Outcome measures
| Measure |
Cigarette Smokers
n=14 Participants
Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened
Own Brand Cigarette: Effects of own brand cigarette use.
ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
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|---|---|
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Progressive Ratio Task - Latency
Unsweetened, 0 mg/ml nicotine
|
161176.93 milliseconds
Standard Deviation 473649.1
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Progressive Ratio Task - Latency
Sweetened, 0 mg/ml nicotine
|
390300.43 milliseconds
Standard Deviation 764004.4
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Progressive Ratio Task - Latency
Unsweetened, 15 mg/ml nicotine
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315803.79 milliseconds
Standard Deviation 636134.5
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Progressive Ratio Task - Latency
Sweetened, 15 mg/ml nicotine
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263130.86 milliseconds
Standard Deviation 651141.0
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Progressive Ratio Task - Latency
Own brand cigarette
|
6500.64 milliseconds
Standard Deviation 6972.8
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SECONDARY outcome
Timeframe: Puff volume will be measured during the approximately 5-minute, 10-puff use bout.Population: Cigarette smokers
The volume of each puff, in ml, averaged over the 10-puff use bout
Outcome measures
| Measure |
Cigarette Smokers
n=14 Participants
Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened
Own Brand Cigarette: Effects of own brand cigarette use.
ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
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|---|---|
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Puff Volume
Unsweetened, 0 mg/ml nicotine
|
207.17 ml
Standard Deviation 124.5
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Puff Volume
Sweetened, 0 mg/ml nicotine
|
233.47 ml
Standard Deviation 157.7
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Puff Volume
Unsweetened, 15 mg/ml nicotine
|
130.57 ml
Standard Deviation 110.4
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Puff Volume
Sweetened, 15 mg/ml nicotine
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166.51 ml
Standard Deviation 141.0
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Puff Volume
Own brand cigarette
|
65.12 ml
Standard Deviation 48.3
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SECONDARY outcome
Timeframe: The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout.Population: Cigarette smokers
The duration of each puff, in seconds, averaged over the 10-puff use bout
Outcome measures
| Measure |
Cigarette Smokers
n=14 Participants
Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened
Own Brand Cigarette: Effects of own brand cigarette use.
ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
|
|---|---|
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Puff Duration
Unsweetened, 0 mg/ml nicotine
|
2.54 seconds
Standard Deviation 1.8
|
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Puff Duration
Sweetened, 0 mg/ml nicotine
|
2.74 seconds
Standard Deviation 1.5
|
|
Puff Duration
Unsweetened, 15 mg/ml nicotine
|
1.60 seconds
Standard Deviation 0.7
|
|
Puff Duration
Sweetened, 15 mg/ml nicotine
|
1.94 seconds
Standard Deviation 1.4
|
|
Puff Duration
Own brand cigarette
|
2.06 seconds
Standard Deviation 1.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)This scale will be used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0-100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)This scale will be used to measure positive and negative affect and consists of 20-items that are scored on a 5-point likert scale ranging from "very slightly or not at all" to "extremely". The items from this scale are scored into two dimensions: Positive Affect and Negative Affect.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)This questionnaire assess a respondent's feelings after recently using tobacco or nicotine products. It has a total of five items that participants rate from not at all to extremely scored 0-100. Each item is scored and analyzed separately (there are no sub-scales).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Heart rate will be measured continuously throughout the session, and will be used to examine changes in HR from baseline (70 minutes) to during (75 minutes) and immediately following a ten-puff bout (80 minutes)Change in heart rate, measure in beats per minute.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout.The time between each puff, in seconds.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Flow rate will be measured during the approximately 5-minute, 10-puff use bout.The rate of air flow during each puff, in ml/second.
Outcome measures
Outcome data not reported
Adverse Events
Cigarette Smokers
ECIG 15 mg Nicotine, Sweetened
ECIG 15 mg Nicotine, Unsweet
ECIG 0 mg Nicotine, Sweetened
ECIG 0 mg Nicotine, Unsweet
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place